CATS TONOMETER LLC — Department of Health and Human Services SBIR Phase II: NEI

Description

Intuor Technologies, LLC - Project Summary Goldmann Contact Tonometry with Optimized Error Correction Intraocular pressure (IOP) measurement is a very important criteria used to assess visual acuity when eye care professionals are diagnosing, treating, and managing potential glaucoma patients. Goldman tonometry (GAT) IOP is recognized as the “gold standard”, but GAT IOP measurements errors have been identified. Phase I results indicated GAT IOP errors were over +/-2mmHg and up to +/-10mmHg in most patients. Those errors result in 50% of the population at risk for vision loss or over treatment. The GAT prism cannot accurately measure IOP due to corneal variabilities such as thicknesses, rigidity curvature, and tear film. Based on Phase I results, Intuor achieved FDA clearance on the CATS reusable prism. The Phase I results also showed CATS Prism improved IOP accuracy a 94% over GAT prism errors. The Phase II work will further the innovation and speed commercialization of CATS prism via ergonomic and manufacturing innovations. Addressing demonstrated market demand, Intuorandapos;s Phase II project will transfer and verify the CATS technology to an injection molded disposable prism with an enhanced ergonomic design. A disposable prism solves many current challenges presented by reusable prisms. The alcohol cleaning methodology for reusable GAT prisms currently used in practice resents a potential health hazard from cross-patient contamination and infection due to improper cleaning techniques. Additionally, reusable prisms are often replaced well past their serviceable life. Intuor plans to eliminate these health hazard by producing a competitively priced disposable prism via one step, injection molding. CATS disposable prism development will lead to a cost- effective prism greatly reducing potential cleaning agent corneal toxicity and infection potential. To achieve the tight tolerances and manufacturing capability requires innovative, iterative designs and multiple injection cycles. The second aspect of the Phase II is a clinically rigorous demonstration of CATS improved IOP accuracy via two distinct clinical studies for ineffectively served populations (pediatric and refractive surgery patients), so clinicians can confidently measure IOP to properly manage these populations. These two groups combined represent 30% of the general population. The clinical trial results will be leveraged into expanding the CATSandapos; currently FDA cleared indications for use with additional claims increasing marketability and utilization across all segments. If successful, these developments described above will eliminate the limitations of the IOP test while preserving its advantages of acceptance, simplicity, and cost.Intuor Technologies, LLC – Project Narrative Goldmann Contact Tonometry with Optimized Error Correction Intuor will build on the successful Phase I grant to engineer, test, and perform a clinical trial on a CATS disposable prism that addresses all known Goldmann Tonometer prism (GAT) intraocular eye pressure (IOP) errors. These GAT errors result in inaccurate IOP readings that are a critical barrier to providing earlier diagnosis and management of glaucoma, as well as treatment of currently ineffectively served populations, such as pediatric and LASIK patients. If successful, advancements from Phase II will enable the standard IOP measurement to realize its full potential as an accurate, cost-effective, safe, and non-invasive tool for the diagnosis and management of glaucoma.